This session will review and discuss enforcement trends surrounding actions brought against FDA-regulated companies for fraudulent practices in late 2022 and early 2023, specifically related to the Foreign Corrupt Practices Act (FCPA) and False Claims Act (FCA), and address FDA, DOJ, and SEC enforcement activities and priorities in these areas. Last fiscal year settlements and judgements in FCA cases exceeded $2 billion, owed in part to health care fraud, unlawful kickbacks, and the rise of the Civil Cyber-Fraud Initiative. Panelists will discuss best practices to identify, avoid, and mitigate potentially fraudulent practices within an organization.

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Luke Cadigan, Partner, Cooley LLP
Susan Cooke Anderson, Trial Counsel, SEC
Fritz Scanlon, Assistant Chief, Health Care Fraud Unit, DOJ
Moderated by Frederick R. Ball, Partner, Duane Morris LLP, Treasurer, FDLI Board of Directors

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